Draft Resolution 1300, 10 December 2024

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Distribution date: 12 December 2024 | Final date for Comment: 17 February 2025

This draft resolution proposes a Normative Instruction which amends the Normative Instruction - IN No 211, of 1 March 2023, which establishes the technological functions, maximum limits and conditions of use for food additives and technology coadjuvants authorized for use in foods.  

Products Covered: Miscellaneous chemical products (HS code(s): 38); Environment. Health protection. Safety (ICS code(s): 13); Food technology (ICS code(s): 67); Chemical technology (ICS code(s): 71)

Regulation Type: Regular notification

Human health Food safety

Draft Resolution 1299, 9 December 2024

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Distribution date: 12 December 2024 | Final date for Comment: 17 February 2025

This draft resolution proposes a Normative Instruction which amends the Normative Instruction - IN No 211, of 1 March 2023, which establishes the technological functions, maximum limits and conditions of use for food additives and technology coadjuvants authorized for use in foods. 

Products Covered: Miscellaneous chemical products (HS code(s): 38); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Regular notification

Food safety Human health

Draft Resolution 1298, 6 December 2024

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Distribution date: 12 December 2024 | Final date for Comment: 11 February 2025

This draft resolution proposes the inclusion of active ingredients A29 - ACETAMIPRID, B26 - BIFENTRIN, B59 - BENALAXYL-M, C07 - KASUGAMYCIN, C09 - CYMONAXIL, C35 - CLOMAZONE, C63 - LAMBDA-CYHALOTHRIN, C74 - CIANTRANILIPROLE, D55 - DINOTEFURANO, F42 - METHYL FLUROXYPYR, F46 - FLUMIOXAZINE, F47 - FLUAZINAM, F68 - FLUXAPIROXADE, G01 - GLYPHOSATE, G05 - GLUFOSINATE-AMMONIUM, L05 - LUFENUROM, M24 - MSMA, M45 - MANDIPROPAMID, P13 - PROFENOFÓS, S09 - SULFENTRAZONA, S13 - S-METOLACHLOR, T81 - TOLPIRALATE, and Z04 - ZOXAMIDA on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

Products Covered: Edible vegetables and certain roots and tubers (HS code(s): 07); Edible fruit and nuts; Peel of citrus fruit or melons (HS code(s): 08); Cereals (HS code(s): 10); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Regular notification

Human health Food safety Maximum residue limits (MRLs)

Model Work Health and Safety Regulations (Engineered Stone) Amendment 2024

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Distribution date: 13 December 2024 | Final date for Comment: 20 April 2025

The Customs (Prohibited Imports) Amendment (Engineered Stone) Regulations 2024 (Amendment Regulations) will come into effect on 1 January 2025. The Amendment Regulations amend the Customs (Prohibited Imports) Regulations 1956 (Prohibited Imports Regulations), to prohibit the import of engineered stone benchtops, panels and slabs into Australia.  This measure is complementary to Australia’s domestic prohibition on the supply, manufacture, processing and installation of engineered stone benchtops, panels and slabs, which commenced on 1 July 2024. The requirement for this measure was signposted in the original notification of 28 June 2024, titled: Model Work Health and Safety Regulations (Engineered Stone) Amendment 2024.  Notification of this addendum regarding the complementary import prohibition for engineered stone, has been made as soon as practicable, taking into account immovable constraints around timing for making of the Amendment Regulations.To protect Australian workers, the manufacture, supply, processing and installation of engineered stone slabs, panels, and benchtops has been prohibited in all Australian states and territories since 1 July 2024 for health and safety reasons, under the Work Health and Safety Regulations 2011 (Cth) (the WHS Regulations). To support this, the Australian Government will implement a prohibition on the importation of engineered stone benchtops, panels and slabs, commencing on 1 January 2025. From this date, engineered stone (as defined below), imported without a valid permit or exemption is classed as a prohibited import, meaning it can be seized at the Australian border without a warrant. As most engineered stone products are imported into Australia, the import ban will provide an extra layer of deterrence at the border, further enhancing these important measures to protect Australian workers. Engineered stone in the Prohibited Import Regulations has the same meaning as in the Work Health and Safety Regulations 2011 (Cth) (the WHS Regulations), as set out below.  Engineered stoneIn the WHS Regulations, crystalline silica substance (CSS) means material that contains at least 1% crystalline silica, determined as a weight/weight (w/w) concentration. Crystalline silica:means crystalline polymorphs of silica; andincludes the following substances:cristobalite;quartz;tridymite;tripoli. In the WHS Regulations, engineered stone:means a CSS that:is an artificial product; andis created by combining natural stone materials with other chemical constituents such as water, resins or pigments; andbecomes hardened; butdoes not include the following:concrete and cement products;bricks, pavers and other similar blocks;ceramic wall and floor tiles;grout, mortar and render;plasterboard;porcelain products;sintered stone;rooftiles. Relying upon the definition from the WHS Regulations ensures alignment between the engineered stone products banned under the domestic use, supply and manufacture prohibition, and those captured under the Prohibited Import Regulations. Under the Prohibited Import Regulations, the importation of engineered stone in the form of benchtops, panels or slabs is prohibited unless:The Work Health and Safety Minister or an authorised person has granted permission for the importation in writing;A permission may only be granted if the Work Health and Safety Minister or authorised person is satisfied that the importation is for either or both of the following purposes:For genuine research and analysis;To sample and identify engineered stone; orThere are exceptional circumstances that justify the importation.a confirmation from Comcare, or an authority of a State or Territory is in force stating that the proposed use of the engineered stone is for genuine research and analysis, or to sample engineered stone.the importation is of a kind of engineered stone benchtops, panels and slabs that is the subject of an exemption granted under of the WHS Regulations, or a corresponding WHS law.  For permits granted by the Work Health and Safety Minister, or an authorised person, examples of exceptional circumstances, include, but are not limited to: If stone waste from Antarctica needed to be imported to be disposed of in Australia; Or in the event an importer wished to import a novel and unanticipated form of engineered stone not previously considered or encountered. Importers must produce copies of the relevant documentation referenced above, to a Collector on request at or before the time of the importation. Information on the Australian Government prohibition on the use, supply and manufacture of engineered stone, can be found at https://www.dewr.gov.au/engineeredstone or https://www.safeworkaustralia.gov.au/esban 

Products Covered: The measure will apply to:Engineered stone slabs, panels, and benchtops. Prohibited ‘engineered stone’ will be defined as an artificial product that contains 1% or more crystalline silica (determined as a weight/weight (w/w) concentration), is created by combining natural stone materials with other chemical constituents (such as water, resins or pigments) and becomes hardened. Engineered stone does not include concrete and cement products, bricks, pavers and other similar blocks, ceramic wall and floor tiles, grout, mortar and render, plasterboard, porcelain products, sintered stone and roof tiles.  This captures the following HS codes:6802: Worked monumental or building stone (except slate) and articles thereof, other than goods of 6801.00.00; mosaic cubes and the like, of natural stone (including slate), whether or not on a backing; artificially coloured granules, chippings and powder, of natural stone (including slate)6802.29.00: Other stone6802.99.00: Other stone6810: Articles of cement, of concrete or of artificial stone, whether or not reinforced6810.19.00: Other6810.91.00: Prefabricated structural components for building or civil engineering6810.99.00: Other6814: Worked mica and articles of mica, including agglomerated or reconstituted mica, whether or not on a support of paper, paperboard or other materials6814.10.00: Plates, sheets and strips of agglomerated or reconstituted mica, whether or not on a support6814.90.00: Other

Regulation Type: Addendum to Regular Notification

Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan on lifting the temporary restrictions on the importation into the territory of Kazakhstan in connection with the improvement of the epizootic situation for highly pathogenic avian influenza from Hungary of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of plant origin, chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy treatment (feathered game), as well as used equipment for keeping, slaughtering and cutting birds

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Distribution date: 18 December 2024 | Final date for Comment: 20 April 2025

Kazakhstan notified in G/SPS/N/KAZ/167 (19 February 2024) the Letters of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of temporary restrictions on the importation into the territory of Kazakhstan from Hungary of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy treatment (feathered game), used equipment for keeping, slaughtering and cutting birds, as well as on the transit of live poultry from the above-mentioned territory through the territory of Kazakhstan.The notified measure was modified by the Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan.

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and butchering birds 

Regulation Type: Addendum to Emergency Notification (SPS)

Pest- or Disease- free Regions / Regionalization Animal diseases Food safety Animal health Human health Avian Influenza Modification of content/scope of regulation

Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety 

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Distribution date: 18 December 2024 | Final date for Comment: 20 April 2025

Therapeutic Goods (Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines) Amendment Order 2024 was registered on the Federal Register of Legislation on 6 December 2024. It amends Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) to introduce new requirements for injectable medicines intended for electrolyte replacement. The Therapeutic Goods Administration (TGA) made these changes to help make quantities of active ingredients clearer on labels and in units important to health professionals. Medicines imported into Australia or released for supply from 1 December 2026 must comply with the updated requirements. For injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less):The label must express potassium chloride quantity in millimoles on the label. Labels must also include the quantity of potassium chloride in weight except in certain circumstances.The label must continue to express the quantity of other active ingredients in weight. It must also include the quantity in millimoles of each ingredient. More information about complying with the new requirements is in Labelling medicines to comply with TGO 91 and TGO 92. Only one of the three notified measures included in the original notification has been adopted at the time of this addendum. However, we have updated the package insert template and guidance to give more clarity to medicine sponsors about providing instructions for preparation. Read more about the results of the public consultation on Updates to Australian medicine labelling rules to support medicine safety.

Products Covered: Medicines

Regulation Type: Addendum to Regular Notification

Labelling

Draft resolution 1301, 16 December 2024

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Distribution date: 19 December 2024 | Final date for Comment: 24 March 2025

This Draft Resolution proposes Good Operating Practices for dental care services.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Dentistry (ICS code(s): 11.060)

Regulation Type: Regular notification

Human health

Draft Resolution 1302, 17 December 2024

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Distribution date: 20 December 2024 | Final date for Comment: 17 February 2025

This draft resolution proposes alteration of the monographies of B33 - BISPIRIBAQUE, B54 - BIXAFEM, B68 - BIXLOZONA, C40 - CLORFENAPIR, F72 - FLUOPIRAM, O19 - ORTOSSULFAMURO, P39 - PIRITIOBAQUE, S19 - SULFOXAFLOR, T61 - TEMBOTRIONE, T70 - TOLFENPIRADE, T71 - METHYL TIENCARBAZONE, on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).  

Products Covered: EDIBLE VEGETABLES AND CERTAIN ROOTS AND TUBERS (HS code(s): 07); Environment. Health protection. Safety (ICS code(s): 13)

Regulation Type: Regular notification

Human health Food safety Maximum residue limits (MRLs)

National Standard of the P.R.C., Alcohol-based liquid fuel

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Distribution date: 20 December 2024 | Final date for Comment: 18 February 2025

This document specifies the product varieties and marks, requirements and test methods, inspection rules, signs, packaging, transportation, storage and safety of alcohol-based liquid fuel.This document applies to methanol-based alcohol liquid fuel, which is used for thermal combustion, rather than spark-ignition or compression-ignition internal combustion.

Products Covered: Alcohol-based liquid fuel (HS code(s): 360610); (ICS code(s): 75.160.20)

Regulation Type: Regular notification

Letter of the Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan on the introduction of temporary restrictions on the importation to the territory of Kazakhstan from the Saskatchewan Province of Canada of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment, feed and feed additives for birds, hunting trophies that have not undergone taxidermy, used equipment for keeping, slaughtering and cutting birds, as well as for transit from the above territory through the territory of Kazakhstan of live birds

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Distribution date: 06 January 2025 | Final date for Comment: 20 April 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of avian influenza was registered in the Saskatchewan Province of Canada. In this regard, since 13 November 2024, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from the territory of the Saskatchewan Province of Canada of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy treatment (feathered game), used equipment for keeping, slaughtering and cutting birds, as well as on the transit of live poultry from the above-mentioned territory through the territory of Kazakhstan. 

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds

Regulation Type: Emergency notifications (SPS)

Human health Animal health Food safety Animal diseases Avian Influenza Pest- or Disease- free Regions / Regionalization

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